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September 20, 2017

Hatch-Waxman Litigation: The Evolving Legal and Regulatory Framework

Since the enactment of the Hatch-Waxman Act, significant alterations to the pharmaceutical industry have taken place, especially in the approval of generic drugs. Years before the approval of the Act, the Federal Food, Drug, and Cosmetic Act (FFDCA) has helped generic companies to get regulatory approval by filing an Abbreviated New Drug Application (ANDA). Nevertheless, only a few number of generic drug have successfully entered the market.

Since the approval of the Act, the number of generic drugs successfully reaching the market has remarkably increased. However, along with the remarkable upsurge in figures, risks and litigation threats arising from Hatch-Waxman have also increased.

Join a panel of key thought leaders and professionals assembled by The Knowledge Group in a LIVE Webcast as they bring the audience to a road beyond the basics of bringing or defending against Hatch-Waxman Litigation and as they delve into the in-depth analysis of the current trends and recent court rulings surrounding this significant topic. Speakers will also provide the audience with practical strategies in bringing out the best in these lawsuits in a rapidly evolving legal climate.

Key topics include:

Hatch-Waxman Act: Fundamentals

Litigation Trends and Pitfalls

Recent Court Decisions

Scope, Privileges and Limitations

Trends, Developments and What Lies Ahead in 2018

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